FDG-PET in Advanced Melanoma

PRIMARY OBJECTIVES:

I. To correlate treatment-induced changes in FDG uptake with changes in tumor size and
progression-free survival (PFS) in patients receiving therapy for advanced melanoma.

II. To correlate treatment-induced changes in FDG uptake with changes in the activity and/or
expression of available molecular biomarkers from patients receiving therapy for advanced
melanoma.

OUTLINE:

Patients undergo FDG-PET/CT up to 2 weeks prior to first dose of therapy, after completion
of the first treatment course (day 21), and after completion of the fourth treatment course
(day 84).

Inclusion Criteria:

- Subjects must have signed Institutional Review Board (IRB)-approved informed consent
documentation

- Subjects must be diagnosed with histologically proven stage IV (metastatic) melanoma
or stage III with bulky disease which may or may not be amenable for surgery and are
receiving therapy at present

- Subjects must be scheduled to begin treatment through the Vanderbilt-Ingram Cancer
Center (VICC) Melanoma Program; this will include patients receiving standard-of-care
chemotherapy, targeted therapy, and/or immunotherapy, as well as patients accrued to
VICC clinical trials for the study of investigational agents

- Subjects must have measurable disease by CT or magnetic resonance imaging (MRI) per
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; to comply with
PET Response Criteria in Solid Tumors (PERCIST) criteria, subjects should have at
least one lesion measuring at least 2 cm in the longest diameter

Exclusion Criteria:

- Subjects who are pregnant or nursing; urine pregnancy test/or serum human chorionic
gonadotropin (HCG) will be performed on women of child bearing potential

- Subjects who have experienced allergic or other adverse reactions in response to
intravenous injection of fluorinated radiotracers and other contrast media used in
PET/CT

- Subjects incapable of giving informed written consent, for the following reasons:

- Inability to adhere to the experimental protocols for any reason

- Inability to communicate with the research team

- Limited ability to give informed consent due to mental disability, altered
mental status, confusion, or psychiatric disorders

- Prisoners or other individuals deemed to be susceptible to coercion